MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number U128

Device Problems Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661)

Patient Problems No Consequences Or Impact To Patient (2199); Complete Heart Block (2627)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that during a follow-up appointment, it was noted that this patient had multiple pacemaker mediated tachycardia episodes and one non-sustained ventricular tachycardia.The patient was given a holter monitor and upon review, it was noted this cardiac resynchronization therapy pacemaker (crt-p) exhibited undersensing of p-waves and crosstalk oversensing on the right ventricular (rv) channel.The oversensing resulted in pacing inhibition greater than 2.5 seconds.The patient also has congenital heart block.The rv lead is a competitor's product.This crt-p was reprogrammed and remains in service.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6706656
• MDR Text Key: 79808163
• Report Number: 2124215-2017-11251
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: (01)00802526559402(17)20190307
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/07/2019
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4266; 4524; 4674; 5826; MISMATCH; U128
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR